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U.S. Department of Health and Human Services

Product Classification

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Device test, prothrombin consumption
Regulation Description Prothrombin consumption test.
Regulation Medical Specialty Hematology
Review Panel Hematology
Product CodeGGQ
Premarket Review Office of In Vitro Diagnostics and Radiological Health (OIR)
Submission Type Enforcement Discretion
Regulation Number 864.7720
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Third Party Review Not Third Party Eligible
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